Specialist - Batch Release

Julphar


Date: 2 weeks ago
City: Ras al-Khaimah
Contract type: Full time
Detailed Job Description

  • Responsible for reviewing and auditing all completed Batch records at all process stages for all dosage forms & to ensure the conformance as per the requirement of cGMP and related SOP’s
  • Responsible for reviewing Batch Documents as per the related checklist of the SOP QA-00-009
  • Responsible for checking the details of vendors used in the batch as per Approved vendor list.
  • Responsible to update the daily tracker for the observations identified and follow up with related departments for corrections in Manufacturing/Packaging documents.
  • Responsible to ensure any deviations/investigations occurred in the batch & documented the deviation/investigation details prior to entry of batch record compliance in SAP
  • Responsible to provide the details of batches entered in SAP as a part of compliance at the end of the day for final release
  • Responsible to issue the batch release certificate for final batch approval.
  • Responsible to perform QMS actions.
  • Perform any other work assigned by the Team Leader/ QA Manager.

Core Competency

  • Must be able to manage tasks and priorities and easily adapt to changing situations
  • Flexible learning abilities
  • Responsible and Accountable
  • Able to handle complexity at system level/ tasks level

Qualification/Functional Knowledge

  • Advanced knowledge in cGMP
  • Proven understanding and well-disciplined while dealing with all stakeholders.
  • Excellent knowledge of reporting procedures and record keeping.
  • Bachelor’s degree in pharmacy
  • 2-4 years of experience

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